Comparative study of sitagliptin, vildagliptin and alogliptin in patients with type 2 diabetes inadequately controlled with metformin and/or sulfonylurea: a randomized, open labeled trial.

Comparative study of sitagliptin, vildagliptin and alogliptin in patients with type 2 diabetes inadequately controlled with metformin and/or sulfonylurea: a randomized, open labeled trial. - Comparison of sitagliptin, vildagliptin and alogliptin.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007078

Enrollment

300

Registered

2012-01-16

Start date

2012-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes

Interventions

Treatment with sitagliptin (50mg/day). Collection of blood and urine at 0, 8, 16 and 24 weeks after administration of the agent. Treatment with vildagliptin (100mg/day). Collection of blood and urine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetic patients who were inadequately controlled (HbA1c (JDS) 6.5~9.0%) with metformin alone, sulfonylurea alone, or metformin and sulfonylurea.

Exclusion criteria

Exclusion criteria: 1.Patients with history of diabetic ketoacidosis or diabetic coma within 6 months prior to the study recruitment. 2.Patients with history of cardiac failure. 3.Patients who received surgical operation during the study. 4.Patients with severe infection or severe trauma. 5.Patients during pregnancy or lactation. 6.Patients with renal insufficienc(serum reatinine > 1.5mg/dl, e-GFR < 30ml/min). 7.Patients with severe liver dysfunction. 8.Patients who received insulin therapy. 9.Patients with history of hypersensitive reaction to sitagliptin, vildagliptin or alogliptin. 10.Patients determined to be inappropriate by physician.

Design outcomes

Primary

Measure	Time frame
FPG and HbA1c at 0, 8, 16 and 24 weeks after administration of sitagliptin, vildagliptin or alogliptin.	—

Secondary

Measure	Time frame
TG, LDL-C, HDL-C, body weight, fasting insulin and glucagon at 0 and 24 weeks after administration of sitagliptin, vildagliptin or alogliptin. AST, ALT,gamma-GTP, fibrinogen and type 4 collagen 7S at 0 and 24 weeks after administration of sitagliptin, vildagliptin or alogliptin. BUN, Cr, e-GFR, microalbuminuria and cystatin C at 0 and 24 weeks after administration of sitagliptin, vildagliptin or alogliptin. Frequency of adverse effects such as hypoglycemia and gastrointestinal symptom after administration of sitagliptin, vildagliptin or alogliptin.	—

Measure

Time frame

TG, LDL-C, HDL-C, body weight, fasting insulin and glucagon at 0 and 24 weeks after administration of sitagliptin, vildagliptin or alogliptin. AST, ALT,gamma-GTP, fibrinogen and type 4 collagen 7S at 0 and 24 weeks after administration of sitagliptin, vildagliptin or alogliptin. BUN, Cr, e-GFR, microalbuminuria and cystatin C at 0 and 24 weeks after administration of sitagliptin, vildagliptin or alogliptin. Frequency of adverse effects such as hypoglycemia and gastrointestinal symptom after administration of sitagliptin, vildagliptin or alogliptin.

—

Countries

Japan

Contacts

Public ContactMasahiro Takihata

Yokohama City Unuversity School of Medicine Department of Endcrinology & Metabolism

m_tackey@hotmail.com0457872800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026